Five Years of Activity in a Priority Sector: The European Commission's Report on Competition Enforcement in the Pharmaceutical Sector (2018-2022)

The European Commission ("Commission") has published a comprehensive report showcasing the strengthening of antitrust and merger control enforcement in the pharmaceutical sector in the EU over the last five years (2018-2022).

The report, produced by the Commission in cooperation with the 27 national competition authorities ("NCAs"), builds on the previous report covering the period 2009-2017, and highlights recent developments in the sector, focusing on medicinal products for human use. It covers developments at both EU and national level, and therefore provides useful insight into the Commission and NCAs' approaches to antitrust and merger enforcement within this priority sector. It includes the UK up to the end of 2020.

Generally, the report highlights the Commission's focus in this area and its strong belief in the crucial role of antitrust enforcement in ensuring that European patients have access to a wider choice of affordable and innovative medicines, a role that was particularly important during the challenging times of the coronavirus pandemic.

While the report is a summary of recent enforcement activity and does not contain new guidance, it summarises key precedents, explains how the Commission looks at pharma markets and sets outs its understanding of how pharma markets work, and clearly demonstrates the Commission's (and NCAs') continued commitment to antitrust and merger control enforcement, reflecting the high level of activity in the pharmaceutical sector.

Antitrust

The Commission and NCAs have been vigilant against anti-competitive practices, investigating more than 60 cases in the sector over the five-year period.

They adopted 26 decisions leading to fines and/or binding commitments to remedy anti-competitive behaviour.

• The fines totalled more than EUR 780 million (although it should be noted EUR 444 million relates to the French Competition Authority's decision which fined Roche and Novartis for abuse of dominance, and which was quashed on appeal (and is on appeal to the Cour de Cassation)).
• Only 2 of these decisions were adopted by the Commission (which in total imposed EUR 60.5 million in fines); a useful reminder that much of the enforcement of the competition rules in the pharmaceutical sector is by NCAs.
• Half of the 26 investigations were initiated ex officio, 9 were triggered by complaints, and 4 were initiated on other grounds (e.g. indicia gathered during a sectoral inquiry).
• Abuse of dominance cases accounted for 50% of the 26 decisions, with the rest being cases concerning restrictive agreements between companies. These include: (i) horizontal agreements between competitors, such as pay-for-delay agreements (8%); (ii) cartels, such as bid rigging (31%); and (iii) vertical agreements, including clauses prohibiting distributors from promoting and selling products of competing manufacturers (11%).

The Commission and NCAs closed 40 cases without an infringement or commitment decision.

The Commission and NCAs have more than 30 investigations currently under way.

The report demonstrates that competition regulators have targeted a wide range of anti-competitive practices, including a mix of abuse of dominance cases and different types of restrictive agreements.

The main practices/cases covered by the Commission in the report include:

• Abuse of Dominance:
  • Patent misuse and vexatious litigation, such as the ongoing Teva Copaxone investigation by the Commission (see our blog post here) and the Spanish CNMC decision against Merck in October 2022 (see our blog post here).
  • Disparagement, including the various Avastin-Lucentis cases in France, Italy, and Belgium and the ongoing Teva Copaxone and Vifor Pharma EU investigations (the UK authority also recently opened a parallel UK investigation of the latter).
  • Rebates and predatory pricing, such as the Dutch NCA AbbVie/Humira and Pfizer/Enbrel investigations in 2021 and the Austrian Merck/temozolomide case concluded in 2021.
  • Excessive pricing, as seen in the Commission Aspen Commitments decision in 2021 (see our blog post here) and the various national cases in the Netherlands, Italy, and Spain in relation to Leadiant and those relating to Aspen in Italy and CD Pharma in Denmark.
  • Discontinuation of supply, such in the UK's CMA investigation into Essential Pharma over concerns that the supply of its bipolar disorder treatment would be withdrawn from the market despite the lack of affordable alternatives available to patients. The CMA's investigation prompted commitments from Essential Pharma to ensure the continued supply of its drug for a period of 5 years (see our blog post on this and other UK cases here).
• Restrictive Agreements:
  • Pay-for-delay agreements, highlighted by the CJEU judgment on Generics UK in 2020 and the Commission's decision in the Cephalon case, which was confirmed by the General Court in October 2023 (see our blog posts here and here). (The report also highlighted two separate cases in Romania where Roche used anti-competitive commercial strategies to prevent or limit sales of generics/biosimilars.)
  • Resale price maintenance, as in the Portuguese decision against Farmodietica in 2022 and the Italian investigation closed with commitments against SOFAR in 2021.
  • Agreeing to limit supply, such as the Romanian decision against 5 suppliers of immunoglobulin in 2021.
  • Cartels, including the Belgian decision in 2022 against Febelco and Pharma Belgium-Belmedis (pharmaceutical wholesalers), for agreeing to apply the same commercial conditions for the distribution of flu vaccines to pharmacists.
  • Coordination between pharmacies and pharmaceutical companies, such as the Lithuanian investigation against LPA and 8 pharmaceutical companies in 2022.
  • Bid rigging, including the Spanish decision in 2021 against the two main suppliers of PET radiopharmaceuticals.
  • Information exchange, such as the UK decisions in 2020 against 4 companies for illegally sharing commercially sensitive information (about prices, volumes supplied, and plans to enter the market) in an attempt to maintain the price of nortriptyline (one of the decisions resulting in two of the parties making a payment of GBP 1 million to the UK National Health Service), covered in our blog post here.

The above is not a comprehensive list of cases or behaviours under investigation, however illustrates the wide range that the Commission and NCAs have covered in the last five years alone.

Merger Control

During 2018-2022, the Commission reviewed more than 30 mergers in the pharmaceutical sector.

It identified competition concerns in 5 out of these 30 cases. The concerns ranged from price increases due to a lessening of competition due to horizontal overlaps reduced access to certain medicines, and reduced innovation in drug development (horizontal overlaps involving pipeline drugs and innovations in particular therapeutic areas).

Of these 5 cases, the Commission cleared 4 following commitments provided by the parties during Phase I to address the Commission's concerns, namely structural remedies in the form of divestitures. These were: Takeda/Shire (2018), GSK/Pfizer Consumer Health Business (2019), AbbVie/Allergan (2020) and Mylan/Upjohn (2020). Interestingly, the Commission specifically calls out Takeda/Shire and AbbVie/Allergan in the report as cases in which remedies were necessary to protect innovation in support of its contention that merger control not only ensures healthy price competition but also is necessary to preserve innovation.

The other case in which the Commission identified concerns was J&J's proposed acquisition of Tachosil (2020), which the parties abandoned after the Commission opened an in-depth investigation due to concerns that the merger could reduce potential competition and innovation in the supply of dual haemostatic patches.

The Commission notes that during the period covered by the report, its intervention rate (i.e. the cases where it prohibited the merger, approved subject to remedies, or the notification was withdrawn in phase II, compared to the total number of notifications) in mergers in the pharmaceutical sector was around 17%. This was higher than the intervention rate across all sectors, which was 5%.

Not surprisingly, the Commission also highlighted the infamous Illumina/Grail deal in the biotech sector although as it was not a pharmaceutical case in the strict sense, it is not included in the report's statistics. The Commission blocked this merger in 2022 (see our blog post here). Illumina/Grail was the first case in which the Commission applied its revised approach to referrals under Article 22 of the EU Merger Regulation which enable the Commission to review cases that are below the EU merger control thresholds and even below all EU Member State national thresholds, following referral of the case from EU Member States (see our blogpost and briefing here). The Commission notes that "The Commission now actively monitors pharmaceutical transactions to identify concentrations that fall below the EU’s and Member States’ notification thresholds but nonetheless merit review by the Commission to ensure that they do not harm effective competition."

Market monitoring and advocacy

In addition to direct enforcement, the report highlights that the Commission and NCAs have carried out more than 60 advocacy and market monitoring exercises between 2018 and 2022.

The Commission notes that these have provided valuable insights into market dynamics, influenced more pro-competitive regulatory designs, and provided guidance to market players.

It is therefore not surprising that with this wealth of material, the Commission's report provides, as noted, a detailed overview of the competitive dynamics of the pharmaceutical market.

Looking Forward

As the Commission continues to adapt and respond to the evolutions and innovations in the pharmaceutical sector, its latest summary of its activities serves as a salutary reminder of the Commission's (and, indeed, NCA's) continued commitment to and focus on antitrust and merger control enforcement in the sector.

In its report, the Commission makes clear that "[e]ffective enforcement of EU competition rules in the pharmaceutical sector remains a matter of high priority and the competition authorities will continue to monitor and be pro-active in investigating potential anti-competitive situations."

The message to pharmaceutical companies is clear and unambiguous. They need to remain vigilant of the key role of competition law in all their activities from settlement and licensing agreements, unilateral conduct such as patent lifecycle strategies to R&D, portfolio management and commercial strategy.

Further information

For further detail on the Commission's approach to competition law in the pharmaceutical sector, please see our chapter on the EU in the Lexology Getting the Deal Through Pharmaceutical Antitrust guide, which can be accessed here. The full guide can be accessed here.

If you have any questions or would like to discuss any of these developments in more detail, please do not hesitate to get in touch with the authors or your usual contact at HSF.